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Washington Drug Letter
July 30, 2012 | Vol. 44 No. 30
FDA Offers Q&A Guidance on Quality Design Requirements
Drugmakers should describe how a product was designed in the quality target product profile (QTPP), which forms the basis for developing critical quality attributes (CQAs) and critical process parameters (CPPs) that ensure the product’s quality over time, the FDA says in a new Q&A guidance on development of quality systems.
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